JP5017730B2 - Skin puncture device - Google Patents

Description

  The present invention relates to a skin puncture device, and more particularly, but not necessarily, to a skin puncture device used for providing a blood sample.

  In the medical and related diagnostic and testing fields, it is often necessary to collect a small blood sample from a subject for the purpose of testing or analyzing blood. A common way to achieve this is to pierce a small needle where the skin vessel is close to the surface. The combination of a needle and its holder is generally known as a lancet. To avoid infection and contamination, the lancet is preferably intended for single use and is disposable. Therefore, they need to be small and inexpensive to manufacture so that the user can carry a plurality of lancets.

  A number of disposable lancet devices are currently commercially available. These include Unistik®, which is manufactured and sold by Owen Mumford Ltd (Woodstock, UK). Current designs include a molded plastic case in which a short, spring-loaded needle is mounted. A trigger is formed in the case, and when it is depressed, the lancet is released and the tip is fired through the opening of the case. Some current designs require the operator to pre-load the spring or set the spring prior to firing. In other designs, the lancet device is supplied already set. In addition, the user generally needs to remove the cap from the front of the instrument or the needle tip prior to firing. Thus, the user must perform at least two steps, sometimes three, to perform the blood collection procedure.

  There is a need for a lancet device or apparatus that is easier to operate than current designs. Of course, the improved design needs to meet high standards for manufacturing costs. Furthermore, the lancet device must be reliable so that it can be supplied to the user in a reliably operable state. The present invention has been devised with the foregoing in mind.

  A skin puncture device according to the present invention is provided. The device is disposed over the open end of the housing part, the lancet and the launching mechanism, and the lancet and launching mechanism disposed within the first housing part, the first and second housing parts being telescopically connected. A membrane for sealing the first housing part containing the mechanism, and movement of the second housing part to the first housing part triggers the firing mechanism, thereby leading the tip of the lancet through the membrane and Drive through the opening in the second housing part.

  This device is easy to use and has the advantage that it can be used with one hand. Most of the components of this device (including the needle) can be manufactured from plastic materials, providing the advantage of being inexpensive and easy to manufacture. The use of a membrane provides the additional advantage that the needle can simply pierce the membrane, rather than requiring a separate cap that the device cannot be used without removal. Furthermore, the entire interior of the first housing part is sealed and kept sterile until the device is fired.

  In certain embodiments, the second housing portion has an external contact surface for contacting the skin to be punctured. The firing mechanism may be configured to be actuated by pushing the first housing part toward the second housing part and the skin to be punctured.

  Preferably, the firing mechanism includes biasing means. More preferably, the biasing means is connected to the inner surface of the first housing part and the lancet. The biasing means may be a spring. In a preferred embodiment, the biasing means is a helical spring.

  The apparatus of the preceding claims is provided with one or more configurations penetrating the membrane when the first and second housing portions are both moved to the second housing portion, the configuration thereafter comprising a launch mechanism. Start.

  In accordance with a preferred embodiment of the present invention, the apparatus comprises locking means provided on the inner surface of the first housing for engaging the lancet and holding the lancet against the action of the biasing means, The above-described configuration in the housing portion is arranged so as to engage with the locking means after the penetration of the membrane to release the lancet. The locking means may include one or more pawls that can be unfolded.

  The biasing means may be configured to retract the needle completely into the housing after the needle is driven through the opening. This advantageously prevents accidental punctures after use.

  Preferably, the first and second housing parts include complementary engageable configurations for resisting relative movement of the first and second housing parts before and / or after operation of the device. . The first housing portion may be telescopically mounted within the second housing portion and may include one or more flanges on its outer surface. The second housing portion may include one or more flanges configured to engage one or more flanges of the first housing portion before and / or after operation of the device.

  In certain embodiments, the second housing portion bends during operation of the device, allowing the first housing portion to telescopically move into the second housing portion.

  The second housing portion may include an opening in a surface that contacts the skin, and the device further includes one or more snap-fit components that can pass through the opening after the device is activated; It may be ensured that the device does not operate further after use. This provides the obvious advantage that the device is already in use and should be discarded. This helps to avoid contamination and risk of infection.

  For a better understanding of the present invention and to show how the invention can be implemented, reference is now made to the accompanying drawings by way of example.

It is a perspective view of a skin puncture apparatus. It is a figure which shows the cross section of the skin puncture apparatus of FIG. 1 by a vertical surface. FIG. 3 is a view showing a cross section of the skin puncture device at the start position at 45 ° with respect to the view of FIG. 2. It is a figure which shows the cross section of the skin puncture apparatus after use with the vertical surface of FIG. FIG. 5 is an exploded cross-sectional view of the skin puncture device after use (180 ° with respect to the devices of FIGS. 1 to 4).

  The drawing shows a skin puncture device designed to puncture a person's skin, for example to give a small blood sample. Typically, this device is used to puncture the belly of a person's finger, leaving a small drop of blood on the finger. This droplet can then be collected for use in taking measurements or inspections, for example using a test strip. The device is shown in FIGS. 1 and 2 in the “ready” or “start” position prior to operation of the device.

  Referring to FIG. 1, skin puncture device 10 has a lower housing portion 12 and an upper housing portion 14. The expressions “bottom” and “top” are chosen for convenience and refer to the embodiments in the orientation shown in FIGS. The housing parts 12 and 14 have a circular or oval cross section. The housing parts 12, 14 are each open at one end, the lower housing part 12 is telescopically mounted in the upper housing part 14, and the open ends of the lower and upper housing parts face each other. Forming a cavity inside the device 10. The closed end of the upper housing part 14 includes a flat surface 16 with an opening 18 located in the center. The opening 20 is also provided around the periphery of the upper surface 16. In the illustrated embodiment, four openings 20 are provided, but embodiments with any number of openings including a single opening are envisioned. An annular flange or projection 23 is provided around the outer surface of the lower housing part 14 and near the open end of the lower housing part.

  With reference to FIG. 2, the flange 23 is visible and two additional flanges or projections 22, 23 are provided around the outer surface of the lower housing part 12. The flanges 21, 22, and 23 have a wedge-shaped outer shape that tapers upward from the lower edges of the flanges 21, 22, and 23. The upper housing part 14 also has a flange or projection 24 located near the open end of the upper housing part. Referring now to FIG. 5, the flange 24 includes a series of wedge-shaped protrusions spaced around the inner surface of the upper housing portion 14 and near the open end of the upper housing portion. The wedge-shaped flange 24 tapers toward the open end of the upper housing part 14. Referring again to FIG. 2, a membrane 25 is provided and extends across the open upper end of the lower housing part 12. The membrane 25 may be made from a number of different materials including metal foil (eg, aluminum), plastic film, paper, rubber, or thermoplastic elastomer (TPE).

  A lancet 26 is provided in the lower housing part 12. The lancet 26 includes a lancet body 28 and a needle 30 embedded in the lancet body 28. The lateral dimension of the upper part of the lancet body 28 is larger than the lateral dimension of the lower part 29 of the lancet body 28. The tip of the needle 30 points vertically upward toward the opening 18.

  The lancet 26 is held at the start position by the lancet holding means 32. The base 34 of the holder 32 is fixed to the inner base of the lower housing part 12. The inwardly extending projection 36 overlaps the upper surface 36 of the lancet body 28 and holds the lancet body in the ready position. The needle 30 is disposed between the protrusions 36.

  The lancet body 28 is urged upward by the urging means and comes into contact with the protrusion 36. In the illustrated embodiment, the biasing means is a helical coil spring 38 that is preloaded (ie, compressed). One end of the spring 38 is held in contact with the base of the lower housing portion 12 by a holding tool 39 protruding inward. The other end of the spring 38 is wound around the lower portion 29 of the lancet body 28.

  In the embodiment shown in FIG. 2, the holder 32 includes an arm extending upward. The holder protrusion 36 is located approximately in the middle of the height of the holder arm 32. The holder arm 32 narrows slightly toward its upper end. The tip 40 of the arm 32 is angled inward and forms a contact surface 42.

  The upper housing portion 14 includes a protrusion or tooth 44 extending downward. The teeth 44 are angled to form a contact surface 46. The teeth 44 are positioned generally above the tip 40 of the holding arm 32, and each contact surface 42 of the holding arm is angled in the same direction as each of the contact surfaces 46 of the teeth 44 positioned above it. The teeth 44 are configured to engage the tip 40 of the holding arm 32 and partially surround the tip of the holding arm, as shown in FIG.

  Next, referring to FIG. 3, the skin puncture device 10 is shown again with the lancet 26 in the starting position and held in place by the lancet holding means 32. The flange 24 of the upper housing part 14 is located between the two uppermost flanges 21, 22 of the lower housing part 12 to limit axial movement and prevent separation of the two housing parts 12, 14. FIG. 4 shows the skin puncture device 10 after use, wherein the flat surface of the lowermost flange 23 of the lower housing part 12 abuts the flat surface of the flange 24 of the upper housing part 14, and the upper and lower housing parts 14, 12 separation is prevented. FIG. 5 also shows the device 10 after use, after the spring 38 has returned to its predetermined position in contact with the base of the lower housing part 12.

  In the starting position of the device 10 (shown in FIGS. 2 and 3), the flange 24 of the upper housing part 14 is held between the flanges 21, 22 of the lower housing part 12. In use, the operator holds the flat upper surface 16 of the upper housing portion 14 against the skin to be punctured by his or another person. Next, the operator pushes the lower housing portion 12 into the upper housing portion 14, and the flange 24 of the upper housing portion 14 flexes and gets over the tapered flanges 22 and 23. Thus, the membrane 25 is carried toward the teeth 44, and the teeth 44 pierce the membrane 25 when in contact with the membrane 25. The pierced membrane 25 is shown in FIG. As the lower housing portion 12 continues into the upper housing portion 14, the teeth 44 contact the tip 40 of the holding arm 32 (as shown in FIG. 4). The angled surface 46 of the teeth 44 pushes the retainer arm 32 outward when in contact with the angled surface 42 of the tip 40 of the retainer 32. This outward movement of the retainer arm 32 continues until the retainer protrusion 36 is moved sufficiently outward to release the lancet 26. The spring 38 then expands rapidly, releasing the energy previously stored therein. This causes the needle 30 to be driven through the lower housing part 12, through the membrane 25 and through the opening 18 in the upper housing part 14 to puncture the human skin. Since the upper portion of the lancet body 28 is larger than the diameter of the opening 18, only the needle 30 can protrude through the opening 18. Accordingly, the length of the needle 32 can be selected to pierce the human skin to a predetermined depth. It should be noted that the separation of the teeth 44 is sufficient to allow the lancet body to pass between them (as shown in FIG. 5).

  At this point, the spring is overstretched after the device is started and when the upper surface of the lancet body contacts the surface of the first housing surrounding the opening 18. The spring 38 retracts (as shown in FIG. 5) and pulls the needle 32 back through the opening 18 into the housing 12, 14. Thereafter, the energy in the spring is insufficient to urge the needle 30 back out of the opening 18 so that the needle 32 is retained in the housing 12, 14 after use. This prevents a skin puncture accident caused by the needle 22 from occurring.

  After use, the flat surface of the lowermost flange 23 of the lower housing part 12 abuts the flat surface of the flange 24 of the upper housing part 14, which ensures that the device is “locked down” after firing. " This provides a clear indication that the device has been used.

  The entire device 10 is sterilized when assembled. The membrane 25 also ensures that sterility is maintained until the device 10 is used.

  The device 10 is very easy to use and can be operated with one hand. The operator simply holds the lower housing part 12 and simply pushes the lower housing part 12 toward the skin with the upper surface 16 of the upper housing part 14 in a position to puncture the skin.

  Those skilled in the art will recognize that various modifications can be made to the above-described embodiments without departing from the scope of the invention.

Claims (14)

A skin puncture device,
First and second housing parts connected in a telescopic manner;
A lancet and launch mechanism disposed within the first housing portion;
A membrane that is disposed over the open end of the first housing part and seals the interior of the first housing part including the lancet and the firing mechanism.
Movement of the second housing part toward the first housing part triggers the firing mechanism, thereby opening the tip of the lancet through the membrane and in the second housing part. A skin puncture device that is driven through.   The apparatus of claim 1, wherein the firing mechanism includes biasing means.   The apparatus of claim 2, wherein the biasing means is coupled to an inner surface of the first housing portion and the lancet.   4. A device according to claim 2 or 3, wherein the biasing means is a spring. The device according to claim 2 , wherein the biasing means is a helical spring.   6. A device according to any of claims 2 to 5, wherein the biasing means is configured to retract the needle completely into the housing after the needle is driven through the opening.   The apparatus according to any one of claims 1 to 6, further comprising lancet holding means for holding the lancet in the first housing part before starting the firing mechanism.   8. A device according to any preceding claim, wherein the second housing part has an external contact surface for contacting the skin to be punctured. The second housing portion is provided with one or more configurations that penetrate the membrane when the first and second housing portions are moved together, the configuration then starting the firing mechanism; The device according to claim 1.   A locking means provided on the inner surface of the first housing for engaging the lancet and holding the lancet against the action of the biasing means; 10. An apparatus according to claim 9 when dependent on claim 2, wherein the apparatus is arranged to engage the locking means to release the lancet after penetration of the membrane.   The apparatus of claim 9, wherein the locking means includes one or more expandable claws.   The first and second housing portions include complementary engageable configurations to resist relative movement of the first and second housing portions before and / or after operation of the device. The apparatus according to claim 1.   The first housing portion is telescopically mounted within the second housing portion and includes one or more flanges on an outer surface thereof, the second housing portion being a portion of the first housing portion. 13. The device of claim 12, comprising one or more flanges and one or more flanges configured to engage one or more flanges before and / or after operation of the device.   14. The device of claim 13, wherein the second housing portion bends during operation of the device and allows the first housing portion to telescopically move into the second housing portion.

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